FDA 483 - Octapharma S.A.S.

Octapharma S.A.S. in Lingolsheim, France, a drug substance and drug product manufacturer, received a Form 483 with two observations. The inspection found deficiencies in the validation of disinfecting agents, specifically regarding their efficacy against spore-forming organisms. Additionally, production equipment was not maintained in a state of good repair, with corrosion observed and a lack of preventive maintenance.